EUCTR2009-012639-13-NL
Active, not recruiting
Not Applicable
Combined intracutaneous and intraperitoneal anaesthesia for postoperative pain reduction after laparoscopic cholecystectomy - Intense Trial
Meander Medical Centre0 sites74 target enrollmentMay 11, 2009
DrugsChirocaine
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Meander Medical Centre
- Enrollment
- 74
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients aged 18\-75 years with an ASA I or II classification who undergo elective laparoscopic cholecystectomy for symptomatic gallstone disease
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •\-Patients with cholecystitis, septic shock from cholangitis, severe acute pancreatitis, advanced cirrhosis, and gallbladder cancer
- •\-Patients with a medical history of epilepsy, cardiac arrhytmias or chronical pain of any kind .
- •\-If a patient is allergic to drugs of the amid type.
- •\-Pregnancy
- •\-Subject suffering from hypotension or hypovolemia.
- •\-Subjects suffering from liver disease
- •\-Subject using drugs which deduce function of the CYP3A4 system like ketoconazol.
- •\-Subject using drugs which deduce function of the CYP1A2 system like the methylxanthines(Fluvoxamin enoxacin)
- •\-Patients with a psychiatric disease or other conditions making them incapable of filling out the questionnaires or completing the objective follow up tests
Outcomes
Primary Outcomes
Not specified
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